US 12,104,210 B2
Blood RNA biomarkers of coronary artery disease
Timothy A. McCaffrey, Silver Spring, MD (US); Georges St. Laurent, III; Ian Toma, Vienna, VA (US); and Richard Katz, Bethesda, MD (US)
Assigned to The George Washington University, Washington, DC (US); and The St. Laurent Institute, Vancouver, WA (US)
Filed by The George Washington University, Washington, DC (US); and The St. Laurent Institute, Vancouver, WA (US)
Filed on Oct. 11, 2021, as Appl. No. 17/498,417.
Application 17/498,417 is a continuation of application No. 15/691,517, filed on Aug. 30, 2017, abandoned.
Claims priority of provisional application 62/382,668, filed on Sep. 1, 2016.
Prior Publication US 2022/0243273 A1, Aug. 4, 2022
Int. Cl. C12Q 1/6883 (2018.01); G01N 33/68 (2006.01)
CPC C12Q 1/6883 (2013.01) [G01N 33/6893 (2013.01); C12Q 2600/112 (2013.01); C12Q 2600/118 (2013.01); C12Q 2600/158 (2013.01); G01N 2800/324 (2013.01)] 17 Claims
 
1. A method of treatment comprising:
(a) obtaining a blood sample from a human subject, wherein the blood sample is stabilized in a guanidinium denaturant;
(b) extracting RNA from the blood sample;
(c) measuring RNA expression levels for a plurality of RNA transcripts, wherein the plurality of RNA transcripts comprises RNA transcripts selected from DGKA, DLG1, ICOSLG, IKZF4/Eos, SMYD3, TCF3, TRIM28, and any combination of any of the foregoing, wherein the expression levels of each of the plurality of RNA transcripts are determined as a percentage of mean expression for each RNA transcript and normalized to calculate a cumulative score for the plurality of RNA transcripts;
(d) comparing the cumulative score to those of a reference set of values derived from patients without coronary artery disease;
(e) identifying the human subject having coronary artery disease based on the comparison performed in step (d) when the cumulative score of the human subject meets or exceeds a threshold fold change compared to that for patients without coronary artery disease, the threshold fold change set at a value of at least 1.5; and
(f) treating the human subject who tests positive for coronary artery disease with administration of a therapeutically effective amount of a medicament comprised of one or more of a statin, an aspirin, an angiotensin-converting enzyme inhibitor, a diuretic, a glucose control medication, a beta blocker, a salt of any of these, or any combination thereof.